A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia (ORION)

Roche

Status and phase

Completed

Phase 3

Conditions

Anemia

Treatments

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Study type

Interventional

Funder types

Industry

Identifiers

NCT00773968

ML21439

2008-003173-40 (EudraCT Number)

Details and patient eligibility

About

This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic renal anemia;
Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
Hb concentration between 10 and 12 g/dL;
Adequate iron status.

Exclusion criteria

Transfusion of red blood cells during previous 2 months;
Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
Active malignant disease.